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Clinical Trial Associate Lausanne Switzerland,  


Posted on : 14 May 2017

Project Description

Debiopharm Group!" is a Swiss-headquartered global biopharmaceutical group including five companies active in the life science areas of drug development, GMP manufacturing of proprietary drugs, diagnostic tools and investment management. Debiopharm International SA is focused on the development of prescription drugs that target unmet medical needs. The company in-licenses and develops promising drug candidates. The products are commercialized by pharmaceutical out-licensing partners to give access to the largest number of patients worldwide. For our Clinical Research & Development Department based in Lausanne we are looking for a Clinical Trial Associate(12-month contract)  Your main responsibilities Support Clinical Trial Managers in daily operational activities related to clinical trials with external vendors (CRO) and internal stakeholders;Generate, finalize and distribute study team agenda and meeting minutes in a timely manner. Act as a support to the CTM for meeting preparation;Collect, verify and upload documents into eRoom (Sharepoint) under the responsibility of the CTM. Ensure a clear and consistent structure and filing method;File and archive all study documents on the eTMF platform under the responsibility of the CTM and ensure inspection readiness of the TMF;Follow up of study budget, preparation and update of purchase orders including management of study invoices;Update and/or track study reporting tools (e.g. weekly follow-up chart, Export of the CRO reporting tool, CTMS);Participate in clinical operations initiatives to reach increased quality, productivity and study management efficiency;Depending on studies:Create and distribute documents for study sites such as study binders;Prepare regulatory files for submission to Health Authorities and Ethics Committees;Contribute to transversal activities such as ClinicalTrials.gov registrations, clinical trial insurances, etc. Your profile University/College degree level or equivalent in a relevant discipline.Proven track record of 3-5 years of experience as CTA or comparable operating experience in Pharma/CRO/healthcare with good knowledge of budget and invoicing requirement, as well as drug development process and medical terminology.Experience in Management and filing of Trial Master File content (Veeva Vault experience is a plus)Excellent spoken and written English and French.Customer orientation and Team spirit, with ability to foster a collaborative team environment in a fast paced matrix organization;Ability to communicate with cross-functional teams.Strong organizational skills with ability to manage stress, pressure and deadlines.Good to advanced computer skills with requirement of MS applications.  Debiopharm can offer you   An international and highly dynamic environment.The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry.The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success. If you fit this profile please send your application using this form.For more information : www.debiopharm.com

Locations

Lausanne switzerland

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